Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC
1. Patients who have provided written informed consent
2. Patients who have urothelial cell carcinoma of the bladder with clinically apparent
stage Ta, grade G1-G2 and satisfy both of the following criteria:
- The maximum number of tumors is 5.
- Each tumor diameter: ≤ 3.5 cm.
3. Age: ≥20 years old at enrollment.
4. The functions of the major organs are adequate, and the following test value criteria
- Neutrophil count ≥1,500/μL
- Platelet count ≥10×10^4/μL
- Hemoglobin ≥10 g/dL
1. Patients with a single, primary bladder cancer of <0.5 cm.
2. Patients with CIS lesions in the bladder or a history thereof.
3. Patients with a history of other than stage Ta, histological grade G1 or G2 disease.
4. Patients experiencing recurrence within 4 months following TURBT for prior NMIBC
(duration between the last TURBT and cystoscopic confirmation of the present
recurrence is within 4 months).
5. Patients without at least a three-month cystoscopically confirmed recurrence-free
interval between the last TURBT and the time of study screening
6. Patients having a bladder tumor with a histological diagnosis other than urothelial
carcinoma of the bladder or a history thereof.
7. Patients who had been administered EO9 in the past.
8. Patients who had been administered any other investigational drug within the past 30
9. Patients having a medical condition that would make it unsafe for them to undergo
TURBT under general or spinal anesthesia.